{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.0","value":"2.4"},{"groupId":"OG001","spread":"1.4","value":"-2.6"}]}],"title":"Fatigue"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.6","value":"2.4"},{"groupId":"OG001","spread":"0.9","value":"-0.4"}]}],"title":"Nausea and Vomiting"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.0","value":"-4.8"},{"groupId":"OG001","spread":"1.5","value":"-5.7"}]}],"title":"Pain"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.0","value":"0.9"},{"groupId":"OG001","spread":"1.4","value":"-1.6"}]}],"title":"Dyspnea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.2","value":"-1.7"},{"groupId":"OG001","spread":"1.7","value":"-4.1"}]}],"title":"Insomnia"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.1","value":"0.2"},{"groupId":"OG001","spread":"1.6","value":"-3.9"}]}],"title":"Appetite loss"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"0.9","value":"-0.8"},{"groupId":"OG001","spread":"1.3","value":"1.6"}]}],"title":"Constipation"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.0","value":"18.2"},{"groupId":"OG001","spread":"1.5","value":"-0.5"}]}],"title":"Diarrhea"},{"categories":[{"measurements":[{"groupId":"OG000","spread":"1.1","value":"-0.7"},{"groupId":"OG001","spread":"1.6","value":"-1.2"}]}],"title":"Financial difficulties"}],"denoms":[{"counts":[{"groupId":"OG000","value":"328"},{"groupId":"OG001","value":"165"}],"units":"Participants"}],"description":"EORTC QLQ-C30 v3.0 is a self-administered questionnaire with multidimensional scales that measures 5 functional domains (physical, role, cognitive, emotional, and social), global health status, and symptom scales of fatigue, pain, nausea and vomiting, dyspnea, loss of appetite, insomnia, constipation and diarrhea, and financial difficulties. Symptom scale ranges from: 1, \"Not at all\"; 2, \"A little\"; 3, \"Quite a bit\"; to 4, \"Very much.\" A linear transformation is applied to standardize the raw scores to range between 0 and 100 per developer guidelines. For symptoms scales, higher scores indicated greater symptom burden. Least Square(LS) Mean was calculated using Mixed Model Repeated Measures (MMRM) model with treatment, Visit, Treatment\\*Visit and Baseline. Small changes are generally defined as at least a 3, 4 or 5 point change from baseline.","dispersionType":"Standard Error","groups":[{"description":"150 mg Abemaciclib orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).","id":"OG000","title":"Abemaciclib + NSAI"},{"description":"Placebo orally every 12 hours plus either 1 mg anastrozole or 2.5 mg letrozole orally once daily for 28 days (28 day cycles).","id":"OG001","title":"Placebo + NSAI"}],"paramType":"LEAST_SQUARES_MEAN","populationDescription":"All randomized participants.","reportingStatus":"POSTED","timeFrame":"Baseline, End of Study (Up to 32 Months)","title":"Change From Baseline to End of Study in Symptom Burden on the EORTC QLQ-C30 Symptom Scale Scores","type":"SECONDARY","unitOfMeasure":"score on a scale"}